What is known about lumateperone tosylate (Caplyta) for psychosis or schizophrenia?

In 2019, the United States Food and Drug Administration approved lumateperone for use in adults with schizophrenia. It is expected to be available in early 2020. Lumateperone affects serotonergic, dopaminergic and glutamatergic systems in the central nervous system. It is a potent serotonergic (5-HT2A) antagonist, partial agonist at presynaptic dopamine receptors and antagonist at postsynaptic dopamine receptors. One published trial of the efficacy of lumateperone reported that lumateperone resulted in significant improvement at 42 mg in Positive and Negative Syndrome Scale (PANSS) total score and Clinical Global Impression. For 28 mg, there was only significant improvement in Clinical Global Impression. Adverse events occurring with lumateperone in more than 5% of patients and at twice the rate of placebo were somnolence, sedation, fatigue and constipation. Serious adverse events were orthostatic hypotension in one patient and convulsions in one patient with a relevant medical history regarding seizures. It is not clear whether lumateperone has advantages over other antipsychotic medications. It may differ in side effect profile, which would be important clinically. Information is found in the FDA medication label.

Medication labels can be found by searching Drugs@FDA at the FDA website. Labels are also available using the Drugs@FDA app for Apple or Android devices. Labels can change over time, and the current label should always be consulted.

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